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Answering Key Questions About COVID-19 Vaccines

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

The US government is investing in rapid development of vaccines against coronavirus disease 2019 (COVID-19), several relying on new technologies.1 In the US, 4 vaccine candidates are in phase 3 studies with initial results expected soon. If studies succeed, 1 or more vaccines may become available within a few months. Clinicians are likely among the first to be offered COVID-19 vaccines and have a key role in helping patients make decisions about vaccination.2 Providing evidence-based information will be particularly important in an environment of polarization and mistrust. This Viewpoint focuses on common questions patients are likely to ask about COVID-19 vaccines.

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Article Information

Corresponding Author: Jesse L. Goodman, MD, MPH, Medicine and Infectious Disease, Georgetown University School of Medicine, 3900 Reservoir Rd, Washington, DC 20057 (jesse.goodman@georgetown.edu).

Published Online: October 16, 2020. doi:10.1001/jama.2020.20590

Conflict of Interest Disclosures: Dr Goodman reported receiving personal fees and nonfinancial support from GlaxoSmithKline and Intellia Therapeutics, and nonfinancial support from US Pharmacopeia outside the submitted work. Dr Grabenstein reported having stock equity in Merck & Co, consulting fees from Valneva, personal fees from serving on the Janssen advisory board, and personal fees from the VBI advisory board outside the submitted work. No other disclosures were reported.

Additional Contributions: We thank Norman W. Baylor, PhD, Biologics Consulting; Luciana L. Borio, MD, In-Q-Tel; Bruce G. Gellin, MD, MPH, Sabin Vaccine Institute; Peter J. Hotez, MD, PhD, Baylor College of Medicine; Glen J. Nowak, PhD, University of Georgia; Paul A. Offit, MD, Children’s Hospital of Philadelphia; and Walter A. Orenstein, MD, Emory University, for their input and Nicole Lurie, MD, MSPH, Coalition for Epidemic Preparedness Innovations (CEPI), Harvard Medical School, for her helpful review.

Additional Information: Dr Goodman reported that he served as the chief scientist of the FDA from January 2009 to March 2014.

References
1.
O’Callaghan  KP , Blatz  AM , Offit  PA .  Developing a SARS-CoV-2 vaccine at warp speed.   JAMA. 2020;324(5):437-438. doi:10.1001/jama.2020.12190 PubMedGoogle ScholarCrossref
2.
Mergler  MJ , Omer  SB , Pan  WK ,  et al.  Association of vaccine-related attitudes and beliefs between parents and health care providers.   Vaccine. 2013;31(41):4591-4595. Published online July 27, 2013. doi:10.1016/j.vaccine.2013.07.039 PubMedGoogle ScholarCrossref
3.
FDA Center for Biologics Evaluation and Research. Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry. June 2020. Accessed October 12, 2020. https://www.fda.gov/media/139638/download
4.
Lurie  N , Sharfstein  JM , Goodman  JL .  The development of COVID-19 vaccines: safeguards needed.   JAMA. 2020;324(5):439-440. doi:10.1001/jama.2020.12461 PubMedGoogle ScholarCrossref
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Shah  A , Marks  PW , Hahn  SM .  Unwavering regulatory safeguards for COVID-19 vaccines.   JAMA. 2020;324(10):931-932. doi:10.1001/jama.2020.15725 PubMedGoogle ScholarCrossref
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Owermohle S. Politico Prescription Pulse. Marks: prepare for “EUA-plus” for Covid vaccines. September 11, 2020. Accessed September 29, 2020. https://www.politico.com/newsletters/prescription-pulse/2020/09/11/marks-prepare-for-eua-plus-for-covid-vaccines-790343
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FDA Center for Biologics Evaluation and Research. Emergency Use Authorization for vaccines to prevent COVID-19: guidance for industry. Accessed October 13, 2020. https://www.fda.gov/media/142749/download
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Rushing coronavirus “Holy Grail” vaccine could turn into a curse. USA Today. September 8, 2020. Accessed September 29, 2020. https://www.usatoday.com/story/opinion/todaysdebate/2020/09/08/rushing-coronavirus-holy-grail-vaccine-could-become-curse-editorials-debates/5743934002/
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Huang  AT , Garcia-Carreras  B , Hitchings  MDT ,  et al.  A systematic review of antibody mediated immunity to coronaviruses: antibody kinetics, correlates of protection, and association of antibody responses with severity of disease.   medRxiv. Preprint posted April 17, 2020. doi:10.1101/2020.04.14.20065771Google Scholar
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